Generic Name and Formulations:
Ketorolac tromethamine 15.75mg; per 100μL nasal spray; contains EDTA.
Indications for SPRIX:
For the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
Limitations Of use:
Not for use in children <2yrs of age.
Use lowest effective dose for shortest duration. 18–64yrs: 1 spray in each nostril (total dose: 31.5mg) every 6–8hrs; max daily dose 126mg (4 doses). ≥65yrs, renally-impaired, or <50kg: 1 spray in one nostril (total dose: 15.75mg) every 6–8hrs; max daily dose 63mg (4 doses). Discard used bottle after 24hrs.
≤17yrs: not established.
Active peptic ulcer, recent GI bleed or perforation. Cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or for whom hemostasis is critical. Aspirin allergy. Pre-op use. Coronary artery bypass graft surgery. Advanced renal disease or at risk for renal failure due to volume depletion. Concomitant probenecid, pentoxifylline. Labor & delivery.
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Inflammatory bowel disease (eg, ulcerative colitis, Crohns disease). Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Avoid spraying into eyes. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation; Cat.D ≥30 weeks gestation: avoid). Nursing mothers.
See Contraindications. Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Possible seizures with phenytoin, carbamazepine. Possible hallucinations with fluoxetine, thiothixene, alprazolam. Caution with nondepolarizing muscle relaxants; monitor for apnea.
Nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash (may be serious), bradycardia, decreased urine output, increased ALT/AST, hypertension, rhinitis; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.
Single-day nasal spray bottle (8 sprays/1.7g bottle)—1, 5
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